title: A randomized phase 3 study comparing once-daily elvitegravir with twice-daily raltegravir in treatment-experienced subjects with HIV-1 infection: 96-week results.
abstract: : This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.
authors.affiliation: Whitman-Walker Health, Washington, DC, USA. relion@whitman-walker.org
authors.forename: Richard
authors.initials: R
authors.lastname: Elion
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.forename: José
authors.initials: J
authors.lastname: Ramón Arribas López
authors.forename: David
authors.initials: D
authors.lastname: Cooper
authors.forename: Franco
authors.initials: F
authors.lastname: Maggiolo
authors.forename: Edmund
authors.initials: E
authors.lastname: Wilkins
authors.forename: Brian
authors.initials: B
authors.lastname: Conway
authors.forename: Ya-Pei
authors.initials: YP
authors.lastname: Liu
authors.forename: Nicolas
authors.initials: N
authors.lastname: Margot
authors.forename: Martin
authors.initials: M
authors.lastname: Rhee
authors.forename: Steven L
authors.initials: SL
authors.lastname: Chuck
authors.forename: Javier
authors.initials: J
authors.lastname: Szwarcberg
mesh_terms: D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D019428:HIV Integrase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D015497:HIV-1; D006801:Humans; D008137:Longitudinal Studies; D011760:Pyrrolidinones / Q000009:adverse effects / Q000627:therapeutic use*; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood*; D000068898:Raltegravir Potassium; D019438:Ritonavir / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D019428:HIV Integrase Inhibitors; D017320:HIV Protease Inhibitors; D011760:Pyrrolidinones; D015363:Quinolones; D012367:RNA, Viral; D000068898:Raltegravir Potassium; C509700:elvitegravir; D019438:Ritonavir